BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Of 1057 HIV-infected participants, 174 participants were not randomized to receive study drug, the main reason being that they did not meet the study criteria (133/174; 76%). 441 randomized to ATV received any drug and 437 randomized to LPV received any drug. 438 and 440 participants randomized to ATV and LPV, respectively, received correct drug.

Reporting Groups

Description

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL) [ Time Frame: Baseline (Day 1) and Week 24 ]

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 [ Time Frame: From Day 1 through Week 96 ]

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96

Measure Description

AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.

Time Frame

From Day 1 through Week 96

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Safety analyses of the treatment period are based on treated population.

Reporting Groups

Description

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values

ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD

LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Participants Analyzed [Units: Participants]

441

437

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 [Units: Participants]

Deaths

6

6

Serious Adverse Events (SAEs)

63

50

Adverse Events (AEs) leading to discontinuation

13

22

No statistical analysis provided for Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96

Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 [ Time Frame: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48. ]